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3884
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2896
Ear, Nose, Throat
488
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2576
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4299
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3987
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983
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935
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978
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768
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696
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631
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580
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526
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522
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Polymer Patient Examination Glove
489
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485
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Intervertebral Fusion Device...
444
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Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Envis, Inc.
Medical Device Manufacturer
·
US , Asheville , NC
Envis, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1999
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Envis, Inc.
Ear, Nose, Throat
✕
1
devices
1-1 of 1
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Cleared
Mar 19, 1999
AROMAPATCH
K984345
·
LRD
Ear, Nose, Throat
·
105d
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Ear, Nose, Throat
1